Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019258
Company: ECOLAB
Company: ECOLAB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHG SCRUB | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | None | No | No |
| CIDA-STAT | CHLORHEXIDINE GLUCONATE | 2% | SOLUTION;TOPICAL | Over-the-counter | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/22/1986 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/10/2018 | SUPPL-26 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019258Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019258Orig1s026ltr.pdf | |
| 01/14/2016 | SUPPL-23 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019258Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019258Orig1s023ltr.pdf | |
| 12/28/2015 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/2015 | SUPPL-21 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019258Orig1s021ltr.pdf |
| 12/16/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/2012 | SUPPL-19 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019258s019ltr.pdf |
| 04/23/2010 | SUPPL-16 | Labeling-Proprietary Name Change |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019258s016ltr.pdf |
| 04/03/2006 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019258s014ltr.pdf |
| 12/20/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/2002 | SUPPL-12 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/15/2005 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19258s011ltr.pdf |
| 04/17/2001 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/16/1995 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/06/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/10/2018 | SUPPL-26 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019258Orig1s026lbl.pdf | |
| 01/14/2016 | SUPPL-23 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019258Orig1s023lbl.pdf |
CHG SCRUB
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION;TOPICAL; 4%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHG SCRUB | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | No | 019258 | ECOLAB |
| EXIDINE | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | No | 019125 | XTTRIUM |
| HIBICLENS | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | Yes | 017768 | MOLNLYCKE HLTH |
CIDA-STAT
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION;TOPICAL; 2%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CIDA-STAT | CHLORHEXIDINE GLUCONATE | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 019258 | ECOLAB |
| EXIDINE | CHLORHEXIDINE GLUCONATE | 2% | SOLUTION;TOPICAL | Over-the-counter | Yes | 019422 | XTTRIUM |